Spinal implant system and method

ABSTRACT

A spinal implant includes a first member defining a longitudinal axis and including a wall that defines an axial cavity. The first member further defines at least one lateral cavity configured for disposal of an instrument and is oriented transverse relative to the longitudinal axis. A second member includes an axial surface defining gear teeth and being configured for disposal with the axial cavity such that the teeth are offset from the longitudinal axis. The instrument is engageable with the teeth to axially translate the second member relative to the first member. Surgical instruments, systems and methods are disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application U.S. patentapplication Ser. No. 14/853,691, filed on Sep. 14, 2015, which is herebyincorporated by reference herein, in its entirety.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to asurgical system that includes a spinal implant and a method for treatinga spine.

BACKGROUND

Spinal disorders such as degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvatureabnormalities, kyphosis, tumor, and fracture may result from factorsincluding trauma, disease and degenerative conditions caused by injuryand aging. Spinal disorders typically result in symptoms including pain,nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes fusion, fixation, corpectomy, discectomy, laminectomy andimplantable prosthetics. In procedures, such as, for example, corpectomyand discectomy, fusion and fixation treatments may be performed thatemploy implants to restore the mechanical support function of vertebrae.This disclosure describes an improvement over these prior technologies.

SUMMARY

In one embodiment, a spinal implant is provided. The spinal implantincludes a first member defining a longitudinal axis and including awall that defines an axial cavity. The first member further defines atleast one lateral cavity configured for disposal of an instrument and isoriented transverse relative to the longitudinal axis. A second memberincludes an axial surface defining gear teeth and being configured fordisposal with the axial cavity such that the teeth are offset from thelongitudinal axis. The instrument is engageable with the teeth toaxially translate the second member relative to the first member. Insome embodiments, surgical instruments, systems and methods aredisclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 2 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure with parts separated;

FIG. 3 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 4 is a perspective break away view of components of one embodimentof a surgical system in accordance with the principles of the presentdisclosure with parts separated;

FIG. 5 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 6 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 7 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosuredisposed with vertebrae;

FIG. 8 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae;

FIG. 9 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae;

FIG. 10 is an enlarged, break away end view of components of thesurgical system shown in FIG. 9;

FIG. 11 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae;

FIG. 12 is an enlarged, break away view of components of the surgicalsystem shown in FIG. 11;

FIG. 13 illustrates perspective views of components of one embodiment ofa surgical system in accordance with the principles of the presentdisclosure;

FIG. 14 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 15 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 16 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 17 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 18 illustrates perspective views of components of one embodiment ofa surgical system in accordance with the principles of the presentdisclosure;

FIG. 19 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 20 illustrates perspective views of components of one embodiment ofa surgical system in accordance with the principles of the presentdisclosure;

FIG. 21 illustrates perspective views of components of one embodiment ofa surgical system in accordance with the principles of the presentdisclosure:

FIG. 22 illustrates perspective views of components of one embodiment ofa surgical system in accordance with the principles of the presentdisclosure;

FIG. 23 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 24 is an enlarged, break away end view of components of thesurgical system shown in FIG. 23;

FIG. 25 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 26 is a side, cross section view of components of one embodiment ofa surgical system in accordance with the principles of the presentdisclosure;

FIG. 27 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure with parts separated;

FIG. 28 is an enlarged, cutaway view of components of the surgicalsystem shown in FIG. 27;

FIG. 29 is a side view of components of the surgical system shown inFIG. 28 with parts separated;

FIG. 30 is a side, cross section view of components of one embodiment ofa surgical system in accordance with the principles of the presentdisclosure;

FIG. 31 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure with parts separated;

FIG. 32 is a break away cross section view of components of the surgicalsystem shown in FIG. 30;

FIG. 33 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 34 is a break away view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 35 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure with parts separated;

FIG. 36 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 37 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 38 is a side view of components of the surgical system shown inFIG. 37;

FIG. 39 is perspective view of components of the surgical system shownin FIG. 37;

FIG. 40 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 41 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 42 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 43 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure; and

FIG. 44 is a plan view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a surgical system that includes an expandable and/or contractiblespinal implant and a method for treating a spine.

In some embodiments, the surgical system includes a spinal implant, suchas, for example, a reduced diameter vertebral body replacement deviceand a surgical instrument, such as, for example, an inserter instrument.In some embodiments, the surgical system includes a spinal implant, suchas, for example, a corpectomy/vertebral body replacement (VBR) devicethat utilizes a surgical instrument, such as, for example, an externalpinion mechanism on an inserter to engage a toothed rack on the VBRdevice. In some embodiments, the diameter of the VBR device is greaterthan 13 millimeters (mm). In some embodiments, the diameter of the VBRdevice is 12 mm. In some embodiments, the reduced diameter VBR deviceincludes a reduced diameter due to a rack of the device being placed offcenter in the VBR device, which is accessible via a side window to anexternal pinion drive of a surgical instrument. In some embodiments, theside window is a bilateral window. In some embodiments, the window is auni-lateral window that facilitates reducing the volume of the VBRdevice. In some embodiments, the uni-lateral window is configured toincrease the strength of the VBR device. In some embodiments, the windowis a uni-lateral window that facilitates engagement with an inserterinstrument.

In some embodiments, the surgical system includes a surgical instrument,such as, for example, a VBR inserter/expander that includes a tiltelement. In some embodiments, the VBR inserter/expander includes apistol grip. In some embodiments, the VBR inserter/expander includesmultiple holes in a proximal end to guide a surgical instrument, suchas, for example, a multi-use driver. In some embodiments, a surgicalinstrument, such as, for example, an inserter includes an externalratcheting/quick release to hold VBR device expansion and/or collapsingof the VBR device, for example, if replacement of the VBR device isdesired. In some embodiments, the VBR inserter/expander includes a tilt,a pistol grip, multiple holes in a proximal end to guide a multi-usedriver, and/or an external ratcheting/quick release.

In some embodiments, the VBR device is expandable. In some embodiments,the VBR device includes a centerpiece. In some embodiments, thecenterpiece is configured to engage an endplate. In some embodiments,the centerpiece has a height without the endplate. In some embodiments,the surgical system comprises a kit including a plurality of VBR devicesand the height of the centerpiece without the endplate has a first sizeof 20 to 25 mm. In some embodiments, the height of the centerpiecewithout the endplate has a second size of 22.5 to 30 mm. In someembodiments, the height of the centerpiece without the endplate has athird size of 28 to 40.5 mm. In some embodiments, the height of thecenterpiece without the endplate has a fourth size of 36.5 to 58 mm. Insome embodiments, the height of the centerpiece without the endplate hasa fifth size of 52.5 to 76.5 mm. In some embodiments, the height of thecenterpiece with the endplate is an additional 3.7 mm. In someembodiments, the surgical system includes one or more lock screws with abreak-off section.

In some embodiments, the surgical system comprises a kit including aplurality of VBR devices and the endplate has various dimensions. Insome embodiments, the dimensions of the endplate are 21.5 mm long and13.5 mm wide. In some embodiments, the dimensions of the endplate are 30mm long and 18.5 mm wide. In some embodiments, the dimensions of theendplate are 42 mm long and 26 mm wide. In some embodiments, theendplate has a textured surface. In some embodiments, the texturedsurface is toothed or barbed. In some embodiments, the endplate includesholes or openings defined by the surface of the endplate. In someembodiments, the endplate is fixed to an end of the centerpiece via ascrew. In some embodiments, the screw includes a break-off section.

In some embodiments, the surgical system includes a surgical instrument,such as, for example, a template. In some embodiments, the template isconfigured to engage with an end of an inserter instrument. In someembodiments, the template and an opposing end of the inserter instrumentcreates an angle. In some embodiments, the angle is 10 degrees. In someembodiments, the template and the inserter instrument engage at an endvia a bearing. In some embodiments, the template and the inserterinstrument engage via a 0 degree angle. In some embodiments, thetemplate and the inserter instrument engage via a 45 degree angle. Insome embodiments, the template and the inserter instrument engage via a90 degree angle. In some embodiments, the template has variousdimensions. In some embodiments, the dimensions of the template are 42mm long and 26 mm wide. In some embodiments, the dimensions of thetemplate are 30 mm long and 18.5 mm wide. In some embodiments, thedimensions of the template are 21.5 mm long and 13.5 mm wide.

In some embodiments, the surgical system includes a surgical instrument,such as, for example, a sizer. In some embodiments, the sizer includes alocking lever to lock the sizer in a closed position. In someembodiments, the sizer includes visual indicia. In some embodiments, apractitioner may select an appropriate VBR device range via the indicia.In some embodiments, the appropriate VBR device range is selectedwithout endplates.

In some embodiments, the surgical system includes a surgical instrument,such as, for example, an inserter that is configured for direct drivingexpansion and/or collapse of a VBR device. In some embodiments, theinserter's overall length is shortened. In some embodiments, theinserter provides accuracy of a locking screw alignment with thecenterpiece and for easier insertion. In some embodiments, the inserterhas a reduced number of parts for cleaning components. In someembodiments, the inserter includes a position of the release buttonconfigured to prevent mishandling. In some embodiments, the inserterincludes a direct driving expansion. In some embodiments, the inserterincludes a tactile feel of distraction forces. In some embodiments, theinserter provides a reduction of potential misalignment due to a limitednumber of components.

In some embodiments, the inserter includes a locking screw driver. Insome embodiments, the locking screw driver includes visual confirmationvia visual indicia of a locking screw tightening. In some embodiments,the locking screw driver includes a locking screw retaining feature. Insome embodiments, the inserter includes a T-handle that is disposed atan end of the inserter. In some embodiments, the inserter is guidedcontinuously to the VBR device.

In some embodiments, the surgical system includes a surgical instrument,such as, for example, a short nut-driver. In some embodiments, thenut-driver is configured for a dual purpose. In some embodiments, thedual purpose of the nut-driver includes the nut-driver as an expansiondriver and the nut-driver as an endplate setscrew driver.

In some embodiments, the VBR device includes titanium 12 mm diametercenterpieces, flat endplates and an implant inserter instrument. In someembodiments, the centerpiece is titanium with a 12 mm diameter. In someembodiments, the centerpiece includes a large size range and includesmultiple approaches. In some embodiments, the surgical system includesan implant inserter instrument. In some embodiments, the surgical systemincludes an anatomical titanium endplate.

In some embodiments, the surgical system includes a vertebral bodyreplacement system. In some embodiments, the vertebral body replacementsystem is employed with a method for treating single or multiplevertebral levels in a cervical and/or thoracolumbar spine to replace acollapsed, damaged, or unstable vertebral body due to tumor or trauma.In some embodiments, the vertebral body replacement system includes aseries of endplates that are attached to a series of centerpieces toform a complete construct to accommodate different anatomical spineregions. In some embodiments, the vertebral body replacement systemincludes two or more endplate options, which include flat or anatomicconfigurations. In some embodiments, an implant inserter instrument willpermit angling the VBR device for mini-invasive approaches, tostraighten and to expand.

In some embodiments, the surgical system comprises a VBR device havingtitanium 12 mm diameter centerpieces, flat endplates and an implantinserter instrument. In some embodiments, the surgical system includes atitanium 12 mm diameter centerpiece. In some embodiments, thecenterpiece includes threaded holes configured for endplate attachment.In some embodiments, the centerpiece is translatable and is configuredfor reversible expansion. In some embodiments, the centerpiece includesa dual expansion rack. In some embodiments, the dual expansion rackincludes a primary set of teeth configured for use without endplates inthe cervical and/or upper thoracic spine. In some embodiments, a lockingbreak-off nut is disposed transversely within an opening/hole on a sideof the centerpiece. In some embodiments, the centerpiece includesopenings/holes that are threaded and configured for instrumentconnection. In some embodiments, the openings/holes are configured forbone fusion assessment.

In some embodiments, the centerpiece is configured to be formed invarious sizes/dimensions. In some embodiments, the range of thedimensions of the centerpiece include but are not limited to a height of15.5 mm and a width of 23.5 mm, a height of 23 mm and a width of 32 mm,a height of 28 mm and a width of 44 mm, a height of 42 mm and a width of58 mm, a height of 56 mm and a width of 72 mm, and a height of 70 mm anda width of 86 mm. In some embodiments, when the endplate is disposed atan end of the centerpiece, the height of the combination of thecenterpiece and the endplate is an additional 4 mm and includes aconnection where the endplate is translatable at an angle of 10 degreesin all directions. In some embodiments, when an endplate is disposed ata proximal end and a distal end of the centerpiece, the height of thecombination of the centerpiece and the endplates is an additional 4 mmfor each end and includes a connection where the endplates aretranslatable at an angle of more or less than 10 degrees in alldirections.

In some embodiments, the surgical system includes a series of flatendplates that can be attached to a series of centerpieces to form acomplete construct. In some embodiments, an overall diameter of thecenterpiece is 12 mm in diameter and facilitates implantation into acervical and thoraco-lumbar spinal region. In some embodiments, aprimary set of teeth are disposed on both ends of the centerpiece forimplantation of the centerpiece without one or two endplates. In someembodiments, the centerpiece is expandable and expansion is locked by alocking break-off screw. In some embodiments, the locking break-offscrew provides a controlled torque tightening.

In some embodiments, the endplate is flat. In some embodiments, therange of the dimensions of the endplate include but are not limited to adiameter of 12 mm, a 14 mm length and a 16 mm width, a 18 mm length anda 22 mm width, and a 24 mm length and a 29 mm width. In someembodiments, the endplate has a 360 degree adjustment when attached toan end of the centerpiece. In some embodiments, when theendplate/endplates are connected to the centerpiece, they aretranslatable at an angle of more or less than 10 degrees in alldirections. In some embodiments, the endplate can be positioned into asurgical site anteriorly, laterally, obliquely, posteriorly and/orpostero-laterally, for example, to be employed with a transforaminallumbar interbody fusion (TLIF).

In some embodiments, the surgical system includes an implant inserterinstrument. In some embodiments, the implant inserter instrument isconfigured to move via one rotation of a knob incrementally. In someembodiments, rotation of the knob is equivalent to one increment, whichis 2 mm.

In some embodiments, the surgical system includes a dual purposescrewdriver, an implant inserter instrument and a lateral knob. In someembodiments, the implant inserter instrument allows implant insertionand provides an oblique angle for minimally invasive approaches. In someembodiments, the implant inserter instrument is moved in an upwarddirection in between two vertebrae and expanded. The expansion isperformed by acting on a gear rack that is actuated by a lateral knob.The dual purpose screwdriver facilitates VBR attachment/unattachment andis disposed on the implant inserter instrument for screwing/unscrewingof the locking break-off screw.

In some embodiments, the surgical system includes an anatomical titaniumendplate with a ball and socket joint formed from a surface of theendplate and is configured to adapt the VBR device to different surgicalapproaches. In some embodiments, the surface of the endplate is texturedwith ribs to improve stiffness of the endplate. In some embodiments, hexholes are disposed in the surface of the endplate to facilitate bone tobone contact, thereby enhancing fusion rate.

In some embodiments, the surgical system includes an anatomical titaniumendplate produced via a selective laser sintering (SLS) process or anelectron beam melting (EBM) process from titanium powder. Theseprocesses allow the endplate to be manufactured in a single piece andalso allow the endplate to be divided into different design spaces. Insome embodiments, the endplate includes a solid design space and aporous lattice design space. In some embodiments, the solid design spaceof the endplate is treated as a solid for manufacture and the porouslattice design space is treated as a design space for trabecular latticecreation. In some embodiments, the SLS and EBM processes offer thepossibility to manufacture endplates with osseointegration surfaces in asingle phase. In some embodiments, there is structural continuitybetween solid and porous sections. In some embodiments, the endplateincludes windows configured to allow bone to bone contact, therebyenhancing fusion rate. In some embodiments, the endplate includes asurface including a porous region and a solid region.

In some embodiments, the surgical system includes an anatomical titaniumendplate having a full porous surface configured to improve a contactarea to bone, and to facilitate penetration through the solid region toenhance fusion rate. In some embodiments, the surgical system includesan anatomical titanium endplate having a solid region and a porousregion that do not have the same thickness. In some embodiments, thethickness of the porous region is 0.5 mm thick and the solid region is0.3 mm thick. In some embodiments, the porous region is 0.6 mm thick andthe solid region is 0.6 mm thick.

In some embodiments, the surgical system includes a conical setscrewconfigured for expansion of the VBR device between 5.5 mm and 8 mmbilaterally. In some embodiments, the surgical system includes anendplate that includes bone teeth that are configured for boneengagement. The endplate is configured for lateral translation. In someembodiments, the surgical system includes an endplate configured for aspherical connection with a cam of a VBR device. In some embodiments,the surgical system includes an endplate configured for a pivotconnection with a cam of a VBR device. In some embodiments, the cam canbe used without the endplate. In some embodiments, the inserterinstrument includes a channel for cam insertion. In some embodiments,the instrument includes teeth engagement between the instrument and thecam. In some embodiments, the cam pivots at an angle of 60 degreesrelative to the instrument.

In some embodiments, the centerpieces are configured to expand from 0 to30 mm via increments of 5 mm. In some embodiments, the centerpieces arestabilized with a cross pin. In some embodiments, the cross pin engagesthe centerpiece transversely via a channel. In some embodiments,expansion is initiated by an implant inserter instrument. In someembodiments, the diameter of the centerpiece is 14 mm. In someembodiments, the centerpiece is manufactured from PEEK material.

In some embodiments, the surgical system includes endplates that aremanufactured from a titanium alloy material. In some embodiments, abearing surface facilitates engagement of an endplate and an end of acenterpiece. In some embodiments, the bearing surface includes twolocking screws. In some embodiments, the bearing surface facilitatestranslation of the endplate at an adaptable angle of more or less than15 degrees relative to the centerpiece. In some embodiments, theendplate includes a large or medium core. In some embodiments, thecenterpiece, endplate and/or endplates are inserted into the surgicalsite via multiple approaches. In some embodiments, the centerpiece,endplate and/or endplates are inserted into the surgical siteanteriorly, laterally, obliquely, posteriorly and/or postero-laterally,for example, to be employed with a TLIF. In some embodiments, theendplate can be adjusted 360 degrees.

In some embodiments, the surgical system includes an additional implantto the VBR implant. In some embodiments, the implant allows bone graftinsertion around the VBR. In some embodiments, the implant is disposedanteriorly or posteriorly. In some embodiments, the implant is a bonegraft container.

In some embodiments, the surgical system includes an in situ attachablebone graft partition for attachment to a small diameter VBR device. Insome embodiments, the in situ attachable bone graft partition preventsbone graft from migrating out the posterior side of the spine after acorpectomy procedure.

In some embodiments, the surgical system includes a bone graftcontainer. In some embodiments, the bone graft container is filled withbone graft and is used in conjunction with large bone resection. In someembodiments, the bone graft container is used only with anterior orlateral surgery.

In some embodiments, the surgical system includes a combination inserterand expander instrument made from titanium. In some embodiments, theinstrument includes a nut driver. In some embodiments, the instrumentincludes a lateral knob. In some embodiments, the nut driver includes along shaft. In some embodiments, the long shaft includes three differentouter diameters. In some embodiments, the instrument includes a knob.

In some embodiments, a method of manufacturing the surgical system isprovided. The method includes the reduction of milling steps. In someembodiments, the method includes the alignment of holes and/or grooves.In some embodiments, the method gives priority to turning versus millingoperations.

In some embodiments, the instrument includes a rack. In someembodiments, the rack is not needed and the surgical system includesonly two implant positions. In some embodiments, the two implantpositions are at 0 degrees and 60 degrees. In some embodiments, theinstrument includes spring blades. In some embodiments, the springblades are not mandatory.

In some embodiments, the instrument includes a handle configured fordual gripping ability. In some embodiments, the instrument includes anindex button that is entirely dismountable. In some embodiments, theinstrument includes a knob to prevent damage on a part of theinstrument. In some embodiments, the surgical system includes acombination inserter and expander instrument. In some embodiments, theinstrument is locked in a flipped position and a straight position via apressure screw. In some embodiments, the surgical system includes avariable angle inserter instrument. In some embodiments, the surgicalsystem includes an instrument set. In some embodiments, the instrumentset includes a nut driver, a spur gear key and a variable angle VBRexpander.

In some embodiments, the variable angle VBR expander includesgraduations to access expansion height. In some embodiments, thevariable angle VBR expander includes toothed gears and gear shafts. Insome embodiments, the gear shafts are symmetrical. In some embodiments,the variable angle VBR expander includes a handle. In some embodiments,the handle is titanium and is configured for weight optimization. Insome embodiments, the gear shaft provides up to 60 degrees ofangulation.

In some embodiments, the instrument can be dismantled for cleaning. Insome embodiments, screws from the handle are removed. A push button andtwo springs disposed in the handle are then pulled in a backwarddirection and a long connecting bar is rotated. The gear shafts are thenremoved. In some embodiments, the instrument includes a fenestratedratchet. In some embodiments, the fenestrated ratchet provides cleaningaccess.

In some embodiments, the nut driver of the instrument is configured forthree functions. In some embodiments, the nut driver is configured forimplant connection to the VBR expander. In some embodiments, the nutdriver is configured for VBR locking after expansion. In someembodiments, the nut driver is configured for endplate tightening. Insome embodiments, the spur gear key of the instrument is configured fora right-handed and/or left-handed person.

In some embodiments, the surgical system includes a variable angleinserter instrument. In some embodiments, the surgical system includesan instrument set. In some embodiments, the instrument set includes animpaction head, a spur gear key, a variable angle VBR expander, a nutdriver and a short nut driver.

In some embodiments, the instrument is configured for implant expansion.In some embodiments, a spur gear key is positioned on multiple sides ofthe expander. In some embodiments, the spur gear key is positioned on atop side of the expander. In some embodiments, the spur gear key ispositioned on a transverse side relative to the top side of theexpander. In some embodiments, the spur gear key is rotated in adirection to facilitate expansion of the implant. In some embodiments,the implant expansion is up to 16 mm. In some embodiments, theinstrument includes visual indicia to indicate a height of expansion. Insome embodiments, expansion is unlocked when an implant isperpendicular. In some embodiments, the instrument locks the implant inplace. In some embodiments, the instrument is configured to unlock andcollapse the implant.

In some embodiments, one or all of the components of the surgical systemare disposable, peel-pack, pre-packed sterile devices used with animplant. One or all of the components of the surgical system may bereusable. The surgical system may be configured as a kit with multiplesized and configured components.

In some embodiments, the present disclosure may be employed to treatspinal disorders such as, for example, degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor and fractures. In someembodiments, the present disclosure may be employed with other ostealand bone related applications, including those associated withdiagnostics and therapeutics. In some embodiments, the disclosedsurgical system and methods may be alternatively employed in a surgicaltreatment with a patient in a prone or supine position, and/or employvarious surgical approaches to the spine, including anterior, posterior,posterior mid-line, lateral, postero-lateral, and/or antero-lateralapproaches, and in other body regions. The present disclosure may alsobe alternatively employed with procedures for treating the lumbar,cervical, thoracic, sacral and pelvic regions of a spinal column. Thesystem and methods of the present disclosure may also be used onanimals, bone models and other non-living substrates, such as, forexample, in training, testing and demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the embodiments taken inconnection with the accompanying drawing figures, which form a part ofthis disclosure. It is to be understood that this application is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting. In some embodiments, as used inthe specification and including the appended claims, the singular forms“a,” “an,” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. Also, as used in the specificationand including the appended claims, the term “tissue” includes softtissue, ligaments, tendons, cartilage and/or bone unless specificallyreferred to otherwise.

The following discussion includes a description of a surgical system andrelated methods of employing the surgical system in accordance with theprinciples of the present disclosure. Alternate embodiments are alsodisclosed. Reference is made in detail to the exemplary embodiments ofthe present disclosure, which are illustrated in the accompanyingfigures. Turning to FIGS. 1-5, there is illustrated components of asurgical system, such as, for example, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials suchas stainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,superelastic metallic alloys (e.g., Nitinol, super elasto-plasticmetals), ceramics and composites thereof such as calcium phosphate(e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK)including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite(HA)-TCP, calcium sulfate, or other resorbable polymers such aspolyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe andtheir combinations.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 is employed, for example, with a minimallyinvasive procedure, including percutaneous techniques, mini-open andopen surgical techniques to deliver and introduce instrumentation and/oran implant, such as, for example, a corpectomy implant, at a surgicalsite within a body of a patient, for example, a section of a spine. Insome embodiments, spinal implant system 10 may be employed with surgicalprocedures, such as, for example, corpectomy and discectomy, whichinclude fusion and/or fixation treatments that employ implants, inaccordance with the principles of the present disclosure, to restore themechanical support function of vertebrae.

Spinal implant system 10 includes a spinal implant 12 having a member,such as, for example, an outer body 14 having a tubular configuration.Body 14 extends in a linear configuration and defines a longitudinalaxis X1. In some embodiments, body 14 may extend in alternateconfigurations, such as, for example, arcuate, offset, staggered and/orangled portions, which may include acute, perpendicular and obtuse. Insome embodiments, spinal implant 12 may include a vertebral bodyreplacement device, a corpectomy implant, an interbody cage, aninterbody spacer and/or an intervertebral implant.

Body 14 extends between an end 16 and an end 18. End 16 defines an endface 20 that engages inner body 40, as described herein. End 18 definesan end face 24.

Body 14 includes a wall, such as, for example, a tubular wall 30 thatdefines a substantially average thickness t1. In some embodiments,thickness t1 may be uniform or have alternate dimensions along thelength of wall 30, for example, portions having a greater or lesserthickness. Wall 30 includes an inner surface 32 that defines an axialcavity 34 extending between ends 16, 18. In some embodiments, wall 30includes a cylindrical cross-section. In some embodiments, thecross-section geometry of wall 30 may have various configurations, suchas, for example, round, oval, oblong, triangular, polygonal havingplanar or arcuate side portions, irregular, uniform, non-uniform,consistent, variable, horseshoe shape, U-shape or kidney bean shape. Insome embodiments, surface 32 is smooth or even. In some embodiments,surface 32 may be rough, textured, porous, semi-porous, dimpled and/orpolished.

Wall 30 includes an inwardly oriented surface that defines a lateralcavity, such as, for example, a side window 36. Window 36 includes anaperture, such as, for example, opening 38. Opening 38 is configured fordisposal of an instrument utilized to facilitate expansion and/orcollapse of body 14 and a member, such as, for example, an inner body 40of spinal implant 12, as described herein. Opening 38 has a circularaperture configuration and is oriented for disposal of a surgicalinstrument, such as, for example, an inserter 150, as described herein,configured for engagement with gear teeth of body 40.

Opening 38 is oriented substantially transverse, such as, for example,perpendicular to axis X1. In some embodiments, opening 38 may bevariously oriented relative to axis X1, such as, for example, parallelor angled, which may include acute and obtuse orientations. In someembodiments, wall 30 may include one or a plurality of openings. In someembodiments, opening 38 may be variously configured, such as, forexample, oval, oblong, triangular, polygonal having planar or arcuateside portions, irregular, uniform, non-uniform, consistent, variable,horseshoe shape, U-shape or kidney bean shape.

In some embodiments, wall 30 defines openings 42 configured to receivean agent, which may include bone graft (not shown) and/or othermaterials, as described herein, for employment in a fixation or fusiontreatment used for example, in connection with a corpectomy. In someembodiments, body 14 may define one or a plurality of openings 42.Openings 42 are configured to facilitate the flow of an agent betweencavity 34 and exterior to body 14 and adjacent vertebrae, as describedherein, to promote bone growth, joint immobilization, therapy and/ortreatment. In some embodiments, openings 42 can be oriented and facing adisc space and/or vertebrae. Openings 42 are oriented substantiallyperpendicular to axis X1. In some embodiments, one or a plurality ofopenings 42 may be variously oriented relative to axis X1, such as, forexample, transverse and/or angled, which may include acute and obtuseorientations.

In some embodiments, the agent may include therapeutic polynucleotidesor polypeptides and bone growth promoting material, which can be packedor otherwise disposed on or about the surfaces of the components ofspinal implant system 10, including spinal implant 12. The agent mayalso include biocompatible materials, such as, for example,biocompatible metals and/or rigid polymers, such as, titanium elements,metal powders of titanium or titanium compositions, sterile bonematerials, such as allograft or xenograft materials, synthetic bonematerials such as coral and calcium compositions, such ashydroxyapatite, calcium phosphate and calcium sulfite, biologicallyactive agents, for example, biologically active agents coated onto theexterior of spinal implant 12 and/or applied thereto for gradual releasesuch as by blending in a bioresorbable polymer that releases thebiologically active agent or agents in an appropriate time dependentfashion as the polymer degrades within the patient. Suitablebiologically active agents include, for example, bone morphogenicprotein (BMP) and cytokines.

In one embodiment, cavity 34 may be configured as a reservoir configuredas a drug depot with medication for pain and may include antibioticsand/or therapeutics. In some embodiments, cavity 34 includes activeagents and may include one or a plurality of therapeutic agents and/orpharmacological agents for release, including sustained release, totreat, for example, pain, inflammation and degeneration. The agent mayinclude pharmacological agents, such as, for example, antibiotics,anti-inflammatory drugs including but not limited to steroids,anti-viral and anti-retroviral compounds, therapeutic proteins orpeptides, therapeutic nucleic acids and combinations thereof.

Body 40 has a tubular configuration and is oriented for disposal withinaxial cavity 34. Body 40 extends and/or contracts in a linearconfiguration relative to axis X1. In some embodiments, body 40 mayextend in alternate configurations, such as, for example, arcuate,offset, staggered and/or angled portions, which may include acute,perpendicular and obtuse.

Body 40 extends between an end 44 and an end 46. End 44 defines an endface 48 configured to engage vertebral tissue and/or endplate 22, asdescribed herein. In some embodiments, the vertebral tissue may includeintervertebral tissue, endplate surfaces and/or cortical bone. In someembodiments, end 44 can include a surface that may be rough, textured,porous, semi-porous, dimpled and/or polished.

Body 40 includes a wall, such as, for example, a tubular wall 52 thatdefines a substantially average thickness t2. In some embodiments,thickness t2 may be uniform or have alternate dimensions along thelength of wall 52, for example, portions having a greater or lesserthickness. Wall 52 includes an inner surface 54 that defines an axialcavity 56 extending between ends 44, 46. In some embodiments, wall 52includes a cylindrical cross-section. In some embodiments, thecross-sectional geometry of wall 52 may have various configurations,such as, for example, round, oval, oblong, triangular, polygonal havingplanar or arcuate side portions, irregular, uniform, non-uniform,consistent, variable, horseshoe shape, U-shape or kidney bean shape. Insome embodiments, surface 54 is smooth or even. In some embodiments,surface 54 may be rough, textured, porous, semi-porous, dimpled and/orpolished. Body 40 is configured for disposal with cavity 34 such thatwalls 30, 52 are concentric with axis X1.

Wall 52 includes a surface 56. Surface 56 includes a gear rack 60 havinga plurality of teeth 62 that are disposed therealong. Teeth 62 aredisposed in a linear, serial configuration along surface 56 and in anoffset configuration relative to axis X1. Teeth 62 extend into opening38 to facilitate engagement with a pinion gear 192 of inserter 150through opening 38, as described herein. Engagement of inserter 150 withteeth 62 axially translates body 40 relative to body 14 between acollapsed configuration and an expanded configuration for disposal in aselected orientation, as described herein.

Wall 52 includes a surface 66 disposed along thickness t2. Surface 66defines an opening, such as, for example, an axial slot 68. Slot 68 isdisposed along axis X1. Slot 68 is configured for engagement with a lock70, as described herein. In some embodiments, the cross-sectionalgeometry of slot 68 may have various configurations, such as, forexample, round, oval, oblong, triangular, polygonal having planar orarcuate side portions, irregular, uniform, non-uniform, consistent,variable, horseshoe shape, U-shape or kidney bean shape. In someembodiments, surface 66 is smooth, even, rough, textured, porous,semi-porous, dimpled and/or polished. In some embodiments, slot 68 mayextend in alternate configurations, such as, for example, arcuate,offset, staggered and/or angled portions, which may include acute,perpendicular and obtuse relative to axis X1.

Lock 70 includes a portion 72 and a portion 74. Portions 72, 74 areconnected at a reduced diameter portion 76 that is frangibly connectedto portion 74. In some embodiments, portion 74 is configured for athreaded engagement with slot 68. In some embodiments, lock 70 extendsthrough a threaded opening of wall 30 to engage slot 68. In someembodiments, portions 72, 74 are fabricated from a fracturing and/orfrangible material such that manipulation of portion 72 relative toportion 74 can fracture and separate portion 72 from portion 74 at apredetermined force and/or torque limit, as described herein. In someembodiments, as force and/or torque is applied to portion 72 andresistance increases, for example, due to fixation of portion 74 withspinal implant 12, as described herein, the predetermined torque andforce limit is approached.

In some embodiments, portions 72, 74 can fracture and separate at apredetermined force or torque limit, which may be in a range ofapproximately 2 Newton meters (N-m) to 8 Nm. In some embodiments,portions 72, 74 may have the same or alternate cross sectionconfigurations, may be fabricated from a homogenous material orheterogeneously fabricated from different materials, and/or alternatelyformed of a material having a greater degree, characteristic orattribute of plastic deformability, frangible property and/or break awayquality to facilitate fracture and separation of portions 72, 74.

Endplate 22 is configured for engagement with end 44 of body 40.Endplate 22 extends between a vertebral engaging surface 80 and asurface 82. Surface 80 includes one or a plurality of tissue penetratingmembers, such as, for example, teeth 84. In one embodiment, one or moreteeth 84 may have various configurations, for example, round, oval,rectangular, polygonal, irregular, tapered, offset, staggered, uniformand non-uniform. In some embodiments, surface 80 may be rough, textured,porous, semi-porous, dimpled, knurled, grooved and/or polished tofacilitate engagement with tissue. In some embodiments, the vertebraltissue may include intervertebral tissue, endplate surfaces and/orcortical bone.

Endplate 22 includes a stratum 86. Stratum 86 includes at least onemating element, such as, for example, an opening 88 configured forengagement with a lock 90 configured for mating engagement with anopening disposed with end face 48, as described herein. In someembodiments, endplate 22 is rotatable about and relative to axis X1 andis moveable in a plurality of angular orientations a relative to axisX1, as shown in FIG. 4. In some embodiments, endplate 22 is moveablerelative to axis X1 between a first angular orientation and a secondangular orientation. In some embodiments, endplate 22 may be disposedwith end 44 for relative movement in orientations relative to axis X1,such as, for example, transverse, perpendicular and/or other angularorientations such as acute or obtuse, co-axial and/or may be offset orstaggered. In some embodiments, endplate 22 may move relative to end 44in alternate planes relative to a body, such as, for example, vertical,horizontal, diagonal, transverse, coronal and/or sagittal planes of abody. In some embodiments, endplate 22 may move relative to end 44 in amulti-axial configuration such that endplate 22 is rotatable to aselected angle through and within an angular range relative to axis X1in a plurality of planes that lie in a cone configuration.

In some embodiments, stratum 86 includes a solid configuration thatincreases the strength of endplate 22. In some embodiments, stratum 86includes an interconnected porous configuration, which facilitates boneingrowth. In some embodiments, stratum 86 includes one or a plurality oflayers. In some embodiments, stratum 86 includes one or a plurality oflayers, which may include solid titanium, porous titanium, solidtitanium-HA composite (porous titanium completely filled with HA) and/orporous titanium-coated with HA. In some embodiments, the cross-sectionalgeometry of endplate 22 may have various configurations, such as, forexample, round, oval, oblong, triangular, polygonal having planar orarcuate side portions, irregular, uniform, non-uniform, consistent,variable, horseshoe shape, U-shape or kidney bean shape.

Lock 90 includes a portion 92 and a portion 94. Portions 92, 94 areconnected at a reduced diameter portion 96 that is tangibly connected toportion 94. In some embodiments, portion 94 is configured for a threadedengagement with end face 48. In some embodiments, portions 92, 94 arefabricated from a fracturing and/or frangible material such thatmanipulation of portion 92 relative to portion 94 can fracture andseparate portion 92 from portion 94 at a predetermined force and/ortorque limit, as described herein. In some embodiments, as force and/ortorque is applied to portion 92 and resistance increases, for example,due to fixation of portion 94 with spinal implant 12, as describedherein, the predetermined torque and force limit is approached.

In some embodiments, portions 92, 94 can fracture and separate at apredetermined force or torque limit, which may be in a range ofapproximately 2 N-m to 8 N-m. In some embodiments, portions 92, 94 mayhave the same or alternate cross section configurations, may befabricated from a homogenous material or heterogeneously fabricated fromdifferent materials, and/or alternately formed of a material having agreater degree, characteristic or attribute of plastic deformability,frangible property and/or break away quality to facilitate fracture andseparation of portions 92, 94.

Endplate 26 is configured for engagement with end 18 of body 14.Endplate 26 extends between a vertebral engaging surface 97 and asurface 98. Surface 97 includes one or a plurality of tissue penetratingmembers, such as, for example, teeth 100. In one embodiment, one or moreteeth 100 may have various configurations, for example, round, oval,rectangular, polygonal, irregular, tapered, offset, staggered, uniformand non-uniform. In some embodiments, surface 97 may be rough, textured,porous, semi-porous, dimpled, knurled, grooved and/or polished tofacilitate engagement with tissue. In some embodiments, the vertebraltissue may include intervertebral tissue, endplate surfaces and/orcortical bone.

Endplate 26 includes a stratum 102. Stratum 102 includes at least onemating element, such as, for example, an opening 104 configured forengagement with a lock 106 configured for mating engagement with anopening disposed with end face 24, as described herein. In someembodiments, endplate 26 is rotatable about and relative to axis X1 andis moveable in a plurality of angular orientations relative to axis X1,similar to that described herein. In some embodiments, endplate 26 ismoveable relative to axis X1 between a first angular orientation and asecond angular orientation. In some embodiments, endplate 26 may bedisposed with end 18 for relative movement in orientations relative toaxis X1, such as, for example, transverse, perpendicular and/or otherangular orientations such as acute or obtuse, co-axial and/or may beoffset or staggered. In some embodiments, endplate 26 may move relativeto end 18 in alternate planes relative to a body, such as, for example,vertical, horizontal, diagonal, transverse, coronal and/or sagittalplanes of a body. In some embodiments, endplate 26 may move relative toend 18 in a multi-axial configuration such that endplate 26 is rotatableto a selected angle through and within an angular range relative to axisX1 in a plurality of planes that lie in a cone configuration.

In some embodiments, stratum 102 includes a solid configuration thatincreases the strength of endplate 26. In some embodiments, stratum 102includes an interconnected porous configuration, which facilitates boneingrowth. In some embodiments, stratum 102 includes one or a pluralityof layers. In some embodiments, stratum 102 includes one or a pluralityof layers, which may include solid titanium, porous titanium, solidtitanium-HA composite (porous titanium completely filled with HA) and/orporous titanium-coated with HA. In some embodiments, the cross-sectionalgeometry of endplate 26 may have various configurations, such as, forexample, round, oval, oblong, triangular, polygonal having planar orarcuate side portions, irregular, uniform, non-uniform, consistent,variable, horseshoe shape, U-shape or kidney bean shape.

In some embodiments, stratum 86 and/or stratum 102 includes one or aplurality of openings configured for disposal of an agent such that theagent may vascularize through the openings. In some embodiments, theagent may be disposed, packed, coated or layered within, on or about thesurfaces of stratum 86 and/or stratum 102. In some embodiments, theagent may include bone growth promoting material, such as, for example,bone graft to enhance fixation of the components and/or surfaces ofstratum 86 and/or stratum 102 with vertebrae. In some embodiments, theagent may include one or a plurality of therapeutic agents and/orpharmacological agents for release, including sustained release, totreat, for example, pain, inflammation and degeneration.

Lock 106 includes a portion 108 and a portion 110. Portions 108, 110 areconnected at a reduced diameter portion 112 that is tangibly connectedto portion 110. In some embodiments, portion 110 is configured for athreaded engagement with end face 24. In some embodiments, portions 108,110 are fabricated from a fracturing and/or frangible material such thatmanipulation of portion 108 relative to portion 110 can fracture andseparate portion 108 from portion 110 at a predetermined force and/ortorque limit, as described herein. In some embodiments, as force and/ortorque is applied to portion 108 and resistance increases, for example,due to fixation of portion 110 with implant 12, as described herein, thepredetermined torque and force limit is approached.

In some embodiments, portions 108, 110 can fracture and separate at apredetermined force or torque limit, which may be in a range ofapproximately 2 N-m to 8 N-m. In some embodiments, portions 108, 110 mayhave the same or alternate cross section configurations, may befabricated from a homogenous material or heterogeneously fabricated fromdifferent materials, and/or alternately formed of a material having agreater degree, characteristic or attribute of plastic deformability,frangible property and/or break away quality to facilitate fracture andseparation of portions 108, 110.

In some embodiments, spinal implant system 10 includes a kit. Componentsof the kit, as shown in FIGS. 3 and 5, include a plurality of bodies 14and/or body 40 having various sizes, such as, for example, body 14 a-14d and having various sizes, such as, for example, bodies 40 a-40 d. Theplurality of bodies includes different sized widths and heights. In someembodiments, body 14 and/or body 40 are configured to be formed invarious sizes/dimensions. In some embodiments, the range of dimensionsof body 14 and/or body 40 include but are not limited to a height of15.5 mm and a width of 23.5 mm, a height of 23 mm and a width of 32 mm,a height of 28 mm and a width of 44 mm, a height of 42 mm and a width of58 mm, a height of 56 mm and a width of 72 mm, and a height of 70 mm anda width of 86 mm. In some embodiments, the kit includes a plurality ofendplates 22, 26, such as, for example, endplates 22 a-22 c. Endplates22, 26 are alternately sized and/or configured relative to one or moredimensions, as described herein, and configured to be interchangeablewith body 14 and/or body 40.

In assembly, operation and use, spinal implant system 10 includingspinal implant 12, similar to that described with regard to FIGS. 1-5,is employed with a surgical procedure, such as, for example, a lumbarcorpectomy for treatment of a spine of a patient including vertebrae V,as shown in FIGS. 6-13. Spinal implant system 10 may also be employedwith other surgical procedures, such as, for example, discectomy,laminectomy, fusion, laminotomy, laminectomy, nerve root retraction,foramenotomy, facetectomy, decompression, spinal nucleus or discreplacement and bone graft and implantable prosthetics including plates,rods, and bone engaging fasteners for securement of spinal implant 12.

Spinal implant system 10 is employed with a lumbar corpectomy includingsurgical arthrodesis, such as, for example, fusion to immobilize a jointfor treatment of an applicable condition or injury of an affectedsection of a spinal column and adjacent areas within a body. Forexample, vertebrae V includes a vertebral level V1 and a vertebral levelV2. Diseased and/or damaged vertebrae and intervertebral discs aredisposed between vertebrae V1 and V2. In some embodiments, spinalimplant system 10 is configured for insertion with a vertebral space tospace apart articular joint surfaces, provide support and maximizestabilization of vertebrae V.

In use, to treat the affected section of vertebrae V, a medicalpractitioner obtains access to a surgical site including vertebrae V inany appropriate manner, such as through incision and retraction oftissues. In some embodiments, spinal implant system 10 may be used inany existing surgical method or technique including open surgery,mini-open surgery, minimally invasive surgery and percutaneous surgicalimplantation, whereby vertebrae V is accessed through a mini-incision,or sleeve that provides a protected passageway to the area. Once accessto the surgical site is obtained, a corpectomy is performed for treatingthe spine disorder. The diseased and/or damaged portions of vertebrae V,and diseased and/or damaged intervertebral discs are removed to create avertebral space S.

A preparation instrument (not shown) is employed to remove disc tissue,fluids, adjacent tissues and/or bone, and scrape and/or remove tissuefrom endplate surface E1 of vertebral level V1 and/or endplate surfaceE2 of vertebral level V2. Spinal implant 12 is provided with at leastone agent, similar to those described herein and as described above, topromote bone growth and fusion to treat the affected section ofvertebrae V.

In some embodiments, a surgical instrument 130 including, such as, forexample, a template 132, as shown in FIG. 6, is inserted into vertebralspace S to determine a size for endplate 22 and/or endplate 26, asdescribed herein. In some embodiments, a surgical instrument, such as,for example, a sizer 134 is utilized to determine an implant height,such as, for example, a height for body 14 and/or body 40. Sizer 134includes an arm 136 configured to engage endplate E1 and an arm 138configured to engage endplate E2. A handle 140 is configured tomanipulate arms 136, 138 to facilitate determination of the height ofthe implant. Handle 140 includes a lock, such as, for example, a lever142 configured to fix arm 136 relative to arm 138 to facilitatemeasurement of the height of vertebral space S. In some embodiments,handle 140 includes a plate 144 that includes indicia 146 to indicatethe height of vertebral space S.

In some embodiments, spinal implant system 10 includes a spinal implantkit having a plurality of alternate endplates 22, 26 that areinterchangeable with a plurality of bodies 14, 30, as described herein.Endplates 22, 26 and bodies 14, 40 are selected for assembly of a spinalimplant 12 with a body 14/body 40 size and/or configuration, endplate22, 26 size and/or configuration, predetermined footprint size and/orexpansion capability.

Endplates 22, 26 are attached to bodies 14, 40, as described herein,with a surgical instrument, such as, for example, a short nut driver148, as shown in FIG. 13. Driver 148 is utilized for a dual purpose.Driver 148 is configured to attach locks 90, 106 with bodies 14, 40 andendplates 22, 26. Driver 148 is rotated to engage locks 90, 106 withopenings 88, 104, Driver 148 is rotated, as shown by arrow E in FIG. 13,to a predetermined force and/or torque limit, to cause portions 108, 92to break off.

Inserter 150 is configured for attachment to spinal implant 12 andconfigured to facilitate insertion and expansion of spinal implant 12,as shown in FIGS. 8-10. Inserter 150 includes a body 152 that extendsbetween an end 154 and an end 156. Body 152 includes a sleeve 158 and ahandle 160. Sleeve 158 includes a surface, such as, for example, atubular housing 162. Handle 160 includes a surface 170. Surface 170defines an opening 172, an opening 174 and an opening 176.

Housing 162 defines a passageway 178 configured for disposal of asurgical instrument, such as, for example, a shaft 180. Passageway 178is in communication with opening 172 such that shaft 180 extends throughpassageway 178. A distal end of shaft 180 is configured for engagementwith a threaded opening 50 of body 14 to releasably fix spinal implant12 with inserter 150. In some embodiments, shaft 180 is threadinglyengaged with body 40. In some embodiments, shaft 180 may includeengaging structures, such as, for example, barbs, tongs, raised elementsand/or spikes to facilitate engagement with spinal implant 12. Aproximal end of shaft 180 is configured for engagement with driver 148to facilitate engagement of shaft 180 with spinal implant 12.

Housing 162 defines a passageway 190 configured for disposal of asurgical instrument, such as, for example, a driver 192. Passageway 190is in communication with opening 174. Driver 192 is configured forinsertion through opening 174 into passageway 190. Driver 192 isconfigured for expanding and contracting body 40 relative to body 14. Adistal end of driver 192 includes a pinion gear portion 198 configuredfor engagement with teeth 62 of rack 60. Pinion gear portion 198 extendsa distance past end 154 to facilitate engagement with spinal implant 12.A proximal end of driver 192 extends through handle 160 and isconfigured for engagement with driver 148 that is connected to andconfigured to rotate driver 192 such that pinion gear portion 198engages spinal implant 12 to expand, contract, collapse and/or extendspinal implant 12. As such, driver 148 is configured to provide atactile feel of distraction forces during expansion. In someembodiments, driver 192 is engageable with an actuator, such as, forexample, a quick release button 186. Button 186 is engageable withdriver 192 to provisionally maintain distraction of vertebrae V, asdescribed herein, or to release the distraction.

Housing 162 defines a passageway 202 configured for moveable disposal ofat least a portion of a surgical instrument, such as, for example, adriver 210, as described herein. Passageway 202 is in communication withopening 176 such that driver 210 can be inserted through opening 176into passageway 202. Passageway 202 guides driver 210 to spinal implant12. Driver 210 includes an engagement portion, such as, for example, aflange 216. Flange 216 is configured to engage lock 70, as describedherein, to releasably fix lock 70 with driver 210. In some embodiments,flange 216 includes configurations, such as, for example, triangular,square, polygonal, hexalobular, star or torx. Body 152 includes anopening 222 for viewing visual indicia 224 disposed on driver 210.Visual indicia 224 is configured to indicate confirmation of fixation oflock 70 with spinal implant 12. Driver 210 includes a rotatable handle226 configured to rotate driver 210 such that lock 70 locks spinalimplant 12 in a fixed configuration. In some embodiments, handle 226 isa T-handle.

Spinal implant 12 is disposed in a first orientation, such that body 14and body 40 are disposed in a concentric configuration with longitudinalaxis X1 and disposed in a telescopic arrangement for delivery andimplantation adjacent vertebral space S. Bodies 14, 40 are seatedconcentrically such that substantially all of inner body 40 is disposedwithin outer body 14 in a nested configuration. Driver 148 actuatesshaft 180, which is engaged with body 14 to releasably fix spinalimplant 12 with inserter 150.

Spinal implant 12 is delivered to the surgical site adjacent vertebrae Vvia inserter 150. Inserter 150 delivers spinal implant 12 into theprepared vertebral space S, between vertebral level V1 and vertebrallevel V2. Driver 192 is inserted through opening 174 into passageway190. Pinion gear portion 198 engages teeth 62 of rack 60. Driver 148 isutilized to actuate driver 192 to expand and contract bodies 14, 40.Driver 192 is rotated, in a direction shown by arrow A in FIG. 10. Asdriver 192 is rotated, pinion gear portion 198 engages teeth 62 of rack60 causing body 40 to axially translate, in the direction shown by arrowB in FIG. 9, relative to body 14 to facilitate expansion of spinalimplant 12. Driver 192 can be rotated in an opposite direction, as shownby arrow C in FIG. 10, to collapse spinal implant 12. As driver 192 isrotated in the opposite direction, pinion gear portion 198 engages teeth62 of rack 60 causing body 40 to axially translate, in a direction shownby arrow D in FIG. 9, relative to body 14 to facilitate contraction ofbody 40 relative to body 14. In some embodiments, inserter 150 isengageable with bodies 14, 40 to provisionally fix bodies 14, 40 in aselected orientation. In some embodiments, expansion of spinal implant12 is provisionally maintained via button 186 while lock screw 70 isinserted to permanently secure expansion of spinal implant 12.

Spinal implant 12 engages and spaces apart opposing endplate surfacesE1, E2 and is secured within vertebral space S to stabilize andimmobilize portions of vertebrae V in connection with bone growth forfusion and fixation of vertebral levels V1, V2. Fixation of spinalimplant 12 with endplate surfaces E1, E2 may be facilitated by theresistance provided by the joint space and/or engagement with endplatesurfaces E1, E2.

Driver 210 is inserted through opening 176 and into passageway 202 toengage lock 70. Handle 226 is manipulated to fix lock 70, as describedherein, with spinal implant 12 to prevent body 40 from axiallytranslating relative to body 14 to fix implant 12 in a selected expandedand/or contracted orientation.

In some embodiments, spinal implant 12 may engage only one endplate. Insome embodiments, agent(s), as described herein, may be applied to areasof the surgical site to promote bone growth. Components of spinalimplant system 10 including spinal implant 12 can be delivered orimplanted as a pre-assembled device or can be assembled in situ.Components of spinal implant system 10 including spinal implant 12 maybe completely or partially revised, removed or replaced in situ. In someembodiments, one or all of the components of spinal implant system 10can be delivered to the surgical site via mechanical manipulation and/ora free hand technique.

In one embodiment, spinal implant 12 may include fastening elements,which may include a locking structure, configured for fixation withvertebral levels V1, V2 to secure joint surfaces and providecomplementary stabilization and immobilization to a vertebral region. Insome embodiments, the locking structure may include fastening elementssuch as, for example, rods, plates, dips, hooks, adhesives and/orflanges. In some embodiments, spinal implant system 10 can be used withscrews to enhance fixation. In some embodiments, spinal implant system10 and any screws and attachments may be coated with an agent, similarto those described herein, for enhanced bony fixation to a treated area.The components of spinal implant system 10 can be made of radiolucentmaterials such as polymers. Radiomarkers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.

In one embodiment, spinal implant system 10 includes a plurality ofspinal implants 12. In some embodiments, employing a plurality of spinalimplants 12 can optimize the amount vertebral space S can be spacedapart such that the joint spacing dimension can be preselected. Theplurality of spinal implants 12 can be oriented in a side by sideengagement, spaced apart and/or staggered.

In some embodiments, use of microsurgical and image guided technologiesmay be employed to access, view and repair spinal deterioration ordamage, with the aid of spinal implant system 10. Upon completion of theprocedure, the non-implanted components, surgical instruments andassemblies of spinal implant system 10 are removed and the incision isclosed.

In one embodiment, as shown in FIGS. 14-16, spinal implant system 10,similar to the systems and methods described with regard to FIGS. 1-13,includes a spinal implant 312, similar to the spinal implants describedherein. Spinal implant 312 includes an outer body 314 having a tubularconfiguration, Body 314 extends in a linear configuration and defines alongitudinal axis X2. Body 314 extends between an end 316 and an end318. End 316 defines an end face 320 configured to engage vertebraltissue and/or an endplate 322, as described herein. End 318 defines anend face 324 that is configured to engage vertebral tissue and/or anendplate 326, as described herein.

Body 314 includes a tubular wall 330. Wall 330 includes an inner surface332 that defines an axial cavity 334 extending between ends 316, 318.Wall 330 includes an inwardly oriented surface that defines a lateralcavity, such as, for example, a side window 336. Window 336 includes anaperture, such as, for example, opening 338. Opening 338 is configuredfor disposal of a surgical instrument utilized to facilitate expansionof body 314 and an inner body 340 of spinal implant 312, as describedherein. Opening 338 has a circular aperture configuration and isoriented for disposal of a surgical instrument, such as, for example, aninserter 450, as described herein, configured for engagement with gearteeth of body 340, as described herein. Opening 338 is orientedsubstantially transverse, such as, for example, perpendicular to axisX2.

Wall 330 includes an inwardly oriented surface that defines a lateralcavity, such as, for example, a side window 344. Window 344 is disposedcontralateral to window 336, as shown in FIG. 16. Window 344 includes anaperture, such as, for example, opening 346. Opening 346 is configuredfor disposal of a surgical instrument utilized to facilitate expansionof body 314 and an inner body 340 of spinal implant 312, as describedherein. Opening 346 has a circular aperture configuration and isoriented for disposal of a surgical instrument, such as, for example, aninserter 450, as described herein, configured for engagement with gearteeth of body 340, as described herein. Opening 346 is orientedsubstantially transverse, such as, for example, perpendicular to axisX2.

In some embodiments, openings 338, 346 may be variously orientedrelative to axis X2, such as, for example, parallel or angled, which mayinclude acute and obtuse orientations. In some embodiments, openings338, 346 may be variously configured, such as, for example, oval,oblong, triangular, polygonal having planar or arcuate side portions,irregular, uniform, non-uniform, consistent, variable, horseshoe shape,U-shape or kidney bean shape.

Body 340 has a tubular configuration and is oriented for disposal withinaxial cavity 334. Body 340 extends in a linear configuration relative toaxis X2. In some embodiments, body 340 may extend in alternateconfigurations, such as, for example, arcuate, offset, staggered and/orangled portions, which may include acute, perpendicular and obtuse.

Body 340 extends between an end 352 and an end 354. End 354 defines anend face 356 configured to engage vertebral tissue and/or endplate 322,as described herein. In some embodiments, end 352 and/or end 354 caninclude a surface that may be rough, textured, porous, semi-porous,dimpled and/or polished. In some embodiments, both or only one of ends352, 354 may engage tissue to provide treatment, as described herein.

Body 340 includes a wall, such as, for example, a tubular wall 356. Wall356 includes an inner surface 358 that defines an axial cavity 360extending between ends 353, 354. In some embodiments, wall 356 includesa cylindrical cross-section. Body 340 is configured for disposal withcavity 334 such that walls 330, 356 are concentric with axis X2.

Wall 356 includes a surface 360. Surface 360 includes a gear rack 362having a plurality of teeth 364 that are disposed therealong. Teeth 364are disposed in a linear, serial configuration along surface 360 in anoffset configuration relative to axis X2. The offset configuration ofteeth 364 cause teeth 364 to extend into opening 338 to facilitateengagement with a pinion gear 528 of inserter 450 through opening 338,as described herein. Engagement of inserter 450 with teeth 364 axiallytranslates body 340 relative to body 314 between a contractedconfiguration and an expanded configuration for disposal in a selectedorientation, as described herein.

Surface 360 includes a gear rack 366 having a plurality of teeth 368that are disposed therealong. Teeth 368 are disposed in a linear, serialconfiguration along surface 360 in an offset configuration relative toaxis X2 and contralateral to teeth 364. The offset configuration ofteeth 368 cause teeth 368 to extend into opening 346 to facilitateengagement with a pinion gear 528 of inserter 450 through opening 346,as described herein. Engagement of inserter 450 with teeth 368 axiallytranslates body 340 relative to body 314 between a contractedconfiguration and an expanded configuration for disposal in a selectedorientation, as described herein

Wall 356 includes a surface 370. Surface 370 defines an opening, suchas, for example, an axial slot 372. Slot 372 is disposed along axis X2.Slot 372 is configured for engagement with a lock 374, similar to lock70, as described herein.

Endplate 322, similar to endplate 22, is configured for engagement withend 352 of body 340. Endplate 322 extends between a vertebral engagingsurface 380 and a surface 382. Surface 380 includes one or a pluralityof tissue penetrating members, such as, for example, teeth 384. In oneembodiment, one or more teeth 384 may have various configurations, forexample, round, oval, rectangular, polygonal, irregular, tapered,offset, staggered, uniform and non-uniform. In some embodiments, surface380 may be rough, textured, porous, semi-porous, dimpled, knurled,grooved and/or polished to facilitate engagement with tissue. In someembodiments, the vertebral tissue may include intervertebral tissue,endplate surfaces and/or cortical bone.

Endplate 322 includes a stratum 386. Stratum 386 includes at least onemating element, such as, for example, an opening 388 configured forengagement with a lock (not shown), similar to lock 90, as describedherein, configured for mating engagement with an opening disposed withend face 356, as described herein. In some embodiments, endplate 322 isrotatable about and relative to axis X2 and is moveable in a pluralityof angular orientations relative to axis X2.

Endplate 326 is configured for engagement with end 318 of body 314.Endplate 326 extends between a vertebral engaging surface 396 and asurface 398. Surface 396 includes one or a plurality of tissuepenetrating members, such as, for example, teeth 400. Endplate 326includes a stratum 402. Stratum 402 includes at least one matingelement, such as, for example, an opening 404 configured for engagementwith a lock (not shown), similar to lock 106, as described herein,configured for mating engagement with an opening disposed with end face324, as described herein. In some embodiments, endplate 326 is rotatableabout and relative to axis X2 and is moveable in a plurality of angularorientations relative to axis X2.

In some embodiments, spinal implant system 10, similar to the systemsand methods described herein, includes a kit. Components of the kit, asshown in FIG. 17, include a plurality of bodies 314 and/or body 340having various sizes, such as, for example, body 314 a-314 f, and havingvarious sizes, such as, for example, body 340 a-340 f. The kit includesa plurality of endplates 322, 326, such as, for example, endplates 322a-322 f. Endplates 322, 326 are alternately sized and/or configuredrelative to one or more dimensions, as described herein, and configuredto be interchangeable with body 314 and/or body 340.

In some embodiments, as shown in FIGS. 18-24, spinal implant system 10,similar to the systems and methods described herein, includes inserter450 configured for attachment to a spinal implant, such as, for example,spinal implant 312 described herein and to facilitate a variable angledinsertion and expansion of spinal implant 312. Inserter 450 includes abody 452 that defines an axis A1 and extends between an end 454 and anend 456. Body 452 includes a sleeve 458 and a handle 460. Sleeve 458includes a surface, such as, for example, a tubular housing 462. Handle460 includes a surface 472. Surface 472 defines an opening 474 and anopening 476. In some embodiments, surface 472 includes an insert, suchas, for example, an impaction head 477.

Housing 462 defines a passageway 478 configured for disposal of a shaft480. Passageway 478 is in communication with opening 476 such that shaft480 extends through passageway 478. A distal end of shaft 480 isconfigured for engagement with body 314 to releasably fix spinal implant312 with inserter 450. In some embodiments, shaft 480 is threadinglyengaged with body 340. In some embodiments, shaft 480 may includeengaging structures, such as, for example, barbs, tongs, raised elementsand/or spikes to facilitate engagement with spinal implant 312. Aproximal end of shaft 480 is configured for engagement with a surgicalinstrument, such as, for example, a driver 486 to facilitate engagementof shaft 480 with spinal implant 312.

Housing 462 defines a passageway 490 configured for disposal of asurgical instrument, such as, for example, a driver 492. Passageway 490is in communication with opening 474 such that driver 492 is insertedthrough opening 474 into passageway 490. Passageway 490 guides driver492 to spinal implant 312. Driver 492 is configured to engage lock 374,as described herein, to releasably fix lock 374 with spinal implant 312.Driver 492 includes a handle 498 configured to facilitate manipulationof driver 492.

Housing 462 defines a passageway 500. Passageway 500 is configured fordisposal of a driver 502. Driver 502 is configured for expanding andcontracting body 340 relative to body 314. A distal end of driver 502includes a pinion gear portion 508 configured for engagement with teeth364 of rack 362. Pinion gear portion 508 extends a distance past end 454to facilitate engagement with spinal implant 312. Driver 502 extendsinto handle 460 for engagement with a spur gear key 510, as describedherein. Pinion gear portion 508 is pivotable to facilitate angulation ofimplant 312 during insertion, as described herein.

Housing 462 defines a passageway 520. Passageway 520 is disposedcontralateral to passageway 500. Passageway 520 is configured fordisposal of a driver 522. Driver 522 is configured for expanding andcontracting body 340 relative to body 314 in conjunction with driver 502for a dual gripping configuration. A distal end of driver 522 includes apinion gear portion 528 configured for engagement with teeth 368 of rack366. Pinion gear portion 528 extends a distance past end 454 tofacilitate engagement with spinal implant 312. A proximal end of driver522 extends into handle 460 for engagement with spur gear key 510, asdescribed herein. In some embodiments, driver 502 is symmetrical withdriver 522. Pinion gear portion 528 is pivotable to facilitateangulation of spinal implant 312 during insertion, as described herein.In some embodiments, an actuator, such as, for example, a quick releasebutton 488 is engageable with driver 502 and/or driver 522 to maintaindistraction of vertebrae V, as described herein, or to release thedistraction.

Spur gear key 510 is engageable with a gear mechanism (not shown)attached with drivers 502, 522. Spur gear key 510 is inserted into oneof openings 530 disposed with handle 460 to engage the drive mechanismto facilitate rotation of gear portions 508, 528 to expand and/orcontract spinal implant 312. Openings 530 are disposed on handle 460 atvarious locations to facilitate expansion and contraction of spinalimplant 312. Handle 460 includes indicia 532 configured to indicategraduations of a height of spinal implant 312 during expansion. Drivers502, 522 are disposed within intermediate part 534 connected to alinkage 540, described herein, and part 534 is configured for slidableengagement with drivers 502, 522.

Inserter 450 includes linkage 540 configured to angle spinal implant 312during implantation. Linkage 540 is connectable with gear portions 508,528 such that gear portions 508, 528 are pivotable about axis A1 topivot spinal implant 312. In some embodiments, linkage 540 is configuredto rotate spinal implant 312 through an angle β relative to axis A1, asshown in FIG. 20. In some embodiments, angle β ranges from 0 to 60degrees. Linkage 540 is actuated by an actuator, such as, for example,driver 486, as described herein.

In one embodiment, as shown in FIGS. 25-29, spinal implant system 10,similar to the systems and methods described with regard to FIGS. 14-24,includes spinal implant 312 engageable with an inserter 650, similar toinserter 450, described herein. Inserter 650 includes a body 652 thatdefines an axis A2. Body 652 includes a sleeve 658 and a handle 660.

Inserter 650 includes a shaft 680 configured for engagement with aportion of body 314 to releasably fix spinal implant 312 with inserter650. Inserter 650 includes a driver 692 configured to engage lock 374,as described herein, to releasably fix lock 374 with spinal implant 312.Inserter 650 includes a driver 702 configured for expanding andcontracting body 340 relative to body 314. Driver 702 includes a piniongear portion 708 configured for engagement with teeth 364 of rack 362.Gear portion 708 is pivotable, as described herein, to facilitateangulation of spinal implant 312 during insertion, as described herein.

Inserter 650 includes a driver 722 configured for expanding andcontracting body 340 relative to body 314 in conjunction with driver 702for a dual gripping configuration. Driver 722 includes a pinion gearportion 728 configured for engagement with teeth 368 of rack 366. Gearportion 728 is pivotable to facilitate angulation of spinal implant 312during insertion, as described herein.

Inserter 650 includes a linkage 740 configured to rotate spinal implant312 during implantation. Linkage 740 is connectable with gear portions708, 728 such that gear portions 708, 728 are pivotable about axis A1 topivot spinal implant 312. In some embodiments, linkage 740 is configuredto rotate spinal implant 312 through an angle relative to axis A2.Linkage 740 is actuated by an actuator, such as, for example, an indexbutton 750. Index button 750 includes a base pin 752, a push sleeve pin754, a spring washer 756 and a lock nut 758. Index button 750 isconfigured to engage linkage 740 to pivot gear portions 708, 728. Indexbutton 750 is configured to facilitate dismantling of inserter 650 forcleaning. In some embodiments, index button 750 is disengaged frominserter 650 via an instrument, such as, for example a lateral knob tofacilitate separation of components of insert 650, as shown in FIG. 27.

In one embodiment, as shown in FIGS. 30-32, spinal implant system 10,similar to the systems and methods described herein, includes spinalimplant 312 engageable with an inserter 850, similar to inserter 450described herein. Inserter 850 includes a body 852 that defines an axisA3. Body 852 includes a sleeve 858 and a handle 860.

Inserter 850 includes a shaft 880 configured for engagement with aportion of body 314 to releasably fix spinal implant 312 with inserter850. Inserter 850 includes a driver 892 configured to engage lock 374,as described herein, to releasably fix lock 374 with spinal implant 312.Inserter 850 includes a driver 902 configured for expanding andcontracting body 340 relative to body 314. Driver 902 includes a piniongear portion 908 configured for engagement with teeth 364 of rack 362.Gear portion 908 is pivotable, as described herein, to facilitateangulation of spinal implant 312 during insertion, as described herein.

Inserter 850 includes a driver 922 configured for expanding andcontracting body 340 relative to body 314 in conjunction with driver 902for a dual gripping configuration. Driver 922 includes a pinion gearportion 928 configured for engagement with teeth 368 of rack 366. Gearportion 928 is pivotable to facilitate angulation of spinal implant 312during insertion, as described herein.

Inserter 850 includes a linkage 940 configured to rotate spinal implant312 during implantation. Linkage 940 is connectable with gear portions908, 928 such that gear portions 908, 928 are pivotable about axis A3 topivot spinal implant 312. In some embodiments, linkage 940 is configuredto rotate spinal implant 312 through an angle relative to axis A3.Linkage 940 is connected to and actuated by an actuator, such as, forexample, an index button 950. Index button 950 includes a pressure screw952 and an assembling screw 954. Manipulation of index button 950 isconfigured to engage linkage 940 to pivot gear portions 908, 928 and fixgear portions 908, 928 in an orientation relative to axis A3. Indexbutton 950 is configured to facilitate dismantling of inserter 850 forcleaning.

In one embodiment, as shown in FIGS. 33-35, spinal implant system 10,similar to the systems and methods described herein, includes spinalimplant 312 engageable with an inserter 1050, similar to inserter 450described herein. Inserter 1050 includes a body 1052 that defines anaxis A4. Inserter 1050 facilitates insertion of spinal implant 312 at anoblique angle for minimally invasive approaches.

Body 1052 includes a sleeve 1058 and a handle 1060. Handle 1060 includesa pistol grip configuration. Handle 1060 includes a grip portion 1062and a lever 1064. Handle 1060 includes a ratchet 1066 configured tofacilitate incremental translation of lever 1064 relative to gripportion 1062.

Inserter 1050 includes a dual purpose driver 1070 configured forengagement with a portion of body 314 to releasably fix spinal implant312 with inserter 1050 and configured to engage lock 374, as describedherein, to releasably fix lock 374 with spinal implant 312. Inserter1050 includes drivers 1080, 1082 configured for expanding andcontracting body 340 relative to body 314. Drivers 1080, 1082 eachinclude a pinion gear portion 1084, 1086 configured for engagement withteeth 364 of rack 362. Gear portions 1084, 1086 are pivotable, asdescribed herein, to facilitate angulation of spinal implant 312 duringinsertion, as described herein and shown in FIG. 34. Gear portions 1084,1086 are actuated by a lateral knob 1090 to expand and contract spinalimplant 312, similar to that described herein.

In some embodiments, as shown in FIGS. 36-39, spinal implant system 10,similar to the systems and methods described herein, includes a spinalimplant 1112. Spinal implant 1112 includes a body 1120 and a body 1122,similar to that described herein, configured for relative contractionand/or expansion when disposed with vertebrae. Spinal implant 1112includes endplates, such as, for example, anatomically configuredendplate 1130. In some embodiments, the anatomic configuration caninclude undulations, arcuate portions, planar portions, angled portions,offset portions, staggered portions and/or preselected geometrycorresponding to an endplate surface, cortical surface and/or cancelloussurface of tissue.

Endplate 1130 includes a stratum 1132. Stratum 1132 includes at leastone mating element, such as, for example, an opening 1134 configured forengagement with body 1120 and/or body 1122 to form a ball and socketjoint 1136. In some embodiments, the mating elements can include biasingmembers, clips, Key/keyway/keyslot, dovetail, tongue/groove,male/female, pin/groove, threaded, barbs, hooks and/or adhesive. In someembodiments, endplate 1130 is rotatable about and relative to an axis ofbody 1120 and/or body 1122 via joint 1136, similar to that describedherein and is moveable in a plurality of angular orientations. In someembodiments, stratum 1132 includes a surface 1138 that defines aplurality of openings, such as, for example, hex holes 1140 configuredto facilitate bone to bone contact at a selected fusion rate. In someembodiments, stratum 1132 includes a plurality of ribs 1142 configuredto enhance stiffness of endplate 1130.

In some embodiments, as shown in FIGS. 40 and 41, spinal implant system10, similar to the systems and methods described herein, includesendplates 1230. Endplate 1230 includes a stratum 1232. Stratum 1232includes at least one mating element, similar to that described hereinand such as, for example, an opening 1234 configured for engagement withbody 1120 and/or body 1122, as described herein, to form a ball andsocket joint, as described herein. In some embodiments, stratum 1232includes a surface 1238 that defines a plurality of openings, such as,for example, windows 1240 configured to facilitate bone to bone contactat a fusion rate. In some embodiments, endplate 1230 includes a porousregion 1242 and a solid region 1244.

In some embodiments, as shown in FIGS. 42 and 43, spinal implant system10, similar to the systems and methods described herein, includesendplates 1330. Endplate 1330 includes a stratum 1332. Stratum 1332includes at least one mating element, similar to that described hereinand such as, for example, an opening 1334 configured for engagement withbody 1120 and/or body 1122, as described herein, to form a ball andsocket joint, as described herein. In some embodiments, stratum 1332includes a surface 1338 that defines a solid region 1340. Stratum 1332includes a surface 1342 that defines a porous region 1344 disposed aboutsurface 1342. In some embodiments, solid region 1340 and porous region1344 comprise different thicknesses.

In one embodiment, as shown in FIG. 44, spinal implant system 10,similar to the systems and methods described herein, includes a spinalimplant 1412, similar to the spinal implants described herein, which isconfigured for relative expansion and/or contraction when disposed withvertebrae V, similar to that described herein. In some embodiments,spinal implant 1412 may include a fixed height and not expandable.

Spinal implant 1412 includes a receptacle, such as, for example, acontainer 1420 configured for disposal of agents, such as, for example,bone graft to facilitate insertion of bone graft with and/orcircumferentially about spinal implant 1412. Container 1420 includes asurface 1422 that defines a cavity 1424 configured for disposal ofspinal implant 1412, Container 1420 includes a surface 1426 that definesa cavity 1428 configured for disposal of bone graft.

In some embodiments, container 1420 is movable and/or adjustablerelative to spinal implant 1412. In some embodiments, container 1420 istranslatable in an anterior-posterior direction for movement and/oradjustment relative to spinal implant 1412. In some embodiments,container 1420 is in-situ attachable with spinal implant 1412 andcomprises a bone graft partition for attachment with spinal implant1412. In some embodiments, container 1420 is attached with spinalimplant 1412 to maintain bone graft with spinal implant 1412 and resistand/or prevent bone graft from migrating out to a posterior side of thespine after a corpectomy procedure.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A spinal implant comprising: a first memberdefining a longitudinal axis and including a wall that defines an axialcavity, the first member further defining at least one lateral cavityconfigured for disposal of an instrument and being oriented transverserelative to the longitudinal axis; a second member including an axialsurface defining gear teeth and being configured for disposal with theaxial cavity such that the teeth are offset from the longitudinal axis;and a lock configured to extend through the wall and into a slot in thesecond member such that the lock simultaneously engages opposing arcuatesurfaces of the slot to independently lock the second member relative tothe first member, wherein the teeth are configured to engage theinstrument to axially translate the second member relative to the firstmember.
 2. A spinal implant as recited in claim 1, further comprising anendplate coupled to the first member, the endplate being pivotablerelative to the first member.
 3. A spinal implant as recited in claim 1,further comprising an endplate coupled to the second member, theendplate being pivotable relative to the second member.
 4. A spinalimplant as recited in claim 1, further comprising: a first endplatecoupled to the first member such that the first endplate is moveable ina plurality of angular orientations relative to the longitudinal axis;and a second endplate coupled to the second member such that the secondendplate is moveable in a plurality of angular orientations relative tothe longitudinal axis.
 5. A spinal implant as recited in claim 1,further comprising a first endplate coupled to the first member and asecond endplate coupled to the second member, at least one of theendplates having a maximum diameter that is greater than a maximumdiameter of the first member.
 6. A spinal implant as recited in claim 1,further comprising an endplate coupled to the first member and a secondlock that extends through an opening in the endplate, the second lockincluding a portion configured for threaded engagement with an end faceof the first member.
 7. A spinal implant as recited in claim 6, whereinthe second lock is coaxial with a central longitudinal axis defined bythe first member.
 8. A spinal implant as recited in claim 6, wherein thesecond lock includes a first portion and a second portion that isconnected to the first portion by a reduced diameter portion.
 9. Aspinal implant as recited in claim 1, further comprising an endplatecoupled to the second member and a second lock that extends through anopening in the endplate, the second lock including a portion configuredfor threaded engagement with an end face of the second member.
 10. Aspinal implant as recited in claim 9, wherein the second lock is coaxialwith a central longitudinal axis defined by the first member.
 11. Aspinal implant as recited in claim 9, wherein the second lock includes afirst portion and a second portion that is connected to the firstportion by a reduced diameter portion.
 12. A spinal implant as recitedin claim 1, further comprising: a first endplate coupled to the firstmember and a second lock that extends through an opening in the firstendplate, the second lock including a portion configured for threadedengagement with an end face of the first member; and a second endplatecoupled to the second member and a third lock that extends through anopening in the second endplate, the third lock including a portionconfigured for threaded engagement with an end face of the secondmember, wherein the second and third locks are coaxial with a centrallongitudinal axis defined by the first member, the second and thirdlocks each including a first portion and a second portion that isconnected to the first portion by a reduced diameter portion.
 13. Aspinal implant as recited in claim 1, wherein the slot is disposed alongthe longitudinal axis.
 14. A spinal implant as recited in claim 1,wherein the lock comprises a first portion and a second portion that isconnected to the first portion by a reduced diameter portion.
 15. Aspinal implant as recited in claim 1, wherein the lock extends through athreaded opening in the wall, the lock including a portion configuredfor threaded engagement with the slot to fix the second member relativeto the first member.
 16. A spinal implant as recited in claim 1, whereinthe wall includes a threaded opening configured for engagement with ashaft of the instrument.
 17. A spinal implant as recited in claim 16,wherein the wall defines openings configured to receive an agent, thethreaded opening being positioned between the openings.
 18. A spinalimplant comprising: a first member defining a longitudinal axis andincluding a wall that includes a smooth inner surface that defines anaxial cavity, the first member further defining at least one lateralcavity oriented transverse relative to the longitudinal axis; a secondmember including an axial surface defining gear teeth and beingconfigured for disposal with the axial cavity such that the teeth areoffset from the longitudinal axis; and a lock configured to extendthrough the wall and into a slot in the second member such that the locksimultaneously engages opposing concave surfaces of the slot toindependently lock the second member relative to the first member,wherein the teeth are configured to engage an instrument to axiallytranslate the second member relative to the first member in oppositedirections.
 19. A spinal implant as recited in claim 18, furthercomprising: a first endplate coupled to the first member and a lock thatextends through an opening in the first endplate, the lock including aportion configured for threaded engagement with an end face of the firstmember; and a second endplate coupled to the second member and a secondlock that extends through an opening in the second endplate, the secondlock including a portion configured for threaded engagement with an endface of the second member, wherein the locks are coaxial with a centrallongitudinal axis defined by the first member, the locks each includinga first portion and a second portion that is connected to the firstportion by a reduced diameter portion.
 20. A spinal implant comprising:a first member defining a longitudinal axis and including a wall thatincludes a smooth inner surface that defines an axial cavity, the firstmember further defining at least one lateral cavity oriented transverserelative to the longitudinal axis; a first endplate coupled to the firstmember such that the first endplate is moveable in a plurality ofangular orientations relative to the longitudinal axis; a second memberincluding an axial surface defining gear teeth and being configured fordisposal with the axial cavity such that the teeth are offset from thelongitudinal axis; a second endplate coupled to the second member suchthat the second endplate is moveable in a plurality of angularorientations relative to the longitudinal axis; and a lock that extendsthrough a threaded opening in the wall, the lock being configured forengagement with opposing arcuate surfaces of a slot in the second memberto independently fix the second member relative to the first member,wherein the teeth are configured to engage an instrument to axiallytranslate the second member relative to the first member in oppositedirections.